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RCCClass II

C-Arm Fluoroscopic X-Ray System

21 CFR 892.1650 / Radiology
FDA source (opens on fda.gov)

RCC is the FDA product code for C-Arm Fluoroscopic X-Ray System, a class II device type, regulated under 21 CFR 892.1650. FDA's definition for this code reads: "Fluoroscopic x-ray system in which the image receptor and x-ray tube housing assembly are connected or coordinated to maintain a spatial relationship. Such a system allows a change in the direction of the beam axis with respect to the patient without moving the patient". As of , FDA records hold no 510(k) clearances under this code and one recall.

Classification record

Product code
RCC
Device name
C-Arm Fluoroscopic X-Ray System
FDA definition
Fluoroscopic x-ray system in which the image receptor and x-ray tube housing assembly are connected or coordinated to maintain a spatial relationship. Such a system allows a change in the direction of the beam axis with respect to the patient without moving the patient.
Regulation
21 CFR 892.1650
Device class
Class II
Review panel
Radiology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
0
Ingested recalls
1

Companies listing this code with FDA

Companies whose registered establishments list this code